MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - UGYTEX¿; MESH, SURGICAL, POLYMERIC

Model Number UGY1510

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Incontinence (1928); Inflammation (1932); Itching Sensation (1943); Pain (1994); Injury (2348); Prolapse (2475); Blood Loss (2597); Fibrosis (3167); No Code Available (3191)

Event Type  Death  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The preoperative and postoperative diagnosis was pelvic pain.The procedure performed was a removal of prior sacrocolpopexy and placement of a new sacrocolpopexy mesh.The patient underwent an additional procedure on (b)(6) 2016.The preoperative and postoperative diagnosis was stress urinary incontinence.The procedure performed was a cystoscopy with regular transvaginal tape sling.At this time a gynecare tvt was implanted.The patient has experienced incontinence, blood loss, prolapse, pain, itching, shaking, fibrosis, inflammation, fragments of mesh, additional surgical interventions.New information indicates patient is deceased.The death certificate indicates the immediate cause breast cancer, neutropenia, septic shock and multiorgan failure (natural causes is checked on the death certificate).There was no indication that a bard product contributed to her death.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: MESH SOFRADIM - UGYTEX¿
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer (Section G): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7635086
• MDR Text Key: 112228857
• Report Number: 9615742-2018-01358
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2013
• Device Model Number: UGY1510
• Device Catalogue Number: UGY1510
• Device Lot Number: PIG00588
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other; Required Intervention
• Patient Age: 69 YR